Senior Validation QC Analyst

Senior Validation QC Analyst - Bangalore/Chennai, India

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

We are currently seeking a Principal Clinical Validation Analyst to join our diverse and dynamic team. As a Principal Clinical Validation Analyst at ICON, you will play a pivotal role in leading the validation processes for clinical data systems and software, ensuring compliance with regulatory standards and the highest levels of data integrity. You will work closely with cross-functional teams to develop validation strategies, perform risk assessments, and implement quality control measures that support the successful execution of clinical trials.

What You Will Be Doing:
Functional lead of multiple studies  providing experience and leadership to EDC validation of clinical studies 
Maintains and develops standards for best testing practices
Contribute to the development of more junior Clinical Validation Analysts, and department initiatives.
Provides experience, technical and SME guidance to more junior Clinical Validation Analysts roles
Leading the validation of clinical data systems, software, and processes to ensure compliance with regulatory requirements and industry standards.
Developing and executing validation plans, including protocols, test scripts, and reports, to support clinical trial data integrity and quality.
Collaborating with clinical, data management, and IT teams to identify validation needs, perform risk assessments, and implement corrective actions.
Providing expertise and guidance on validation best practices, keeping up-to-date with industry trends, regulatory changes, and technological advancements.
Ensuring thorough documentation of all validation activities, maintaining clear and accurate records to support audits and inspections.

Your Profile:
Functional Knowledge:
• Strong functional knowledge level of EDC Clinical Systems
•Typical years of experience 8+. An equivalent combination of education, training and relevant experience may be considered in place of the education and experience stated

Business Expertise:
• Adds value through strong knowledge of best practices and application to customer needs. May contribute internally to training material
• Good working knowledge of protocol interpretation
• Other responsibilities may be assigned as required

Leadership:
• Small to Medium portfolio oversight of functional project teams and/or provides holistic review of client deliverables.
• Typically includes client integration.
• Established Mentor

Problem Solving:
• Lead others to solve complex problems; use sophisticated analytical thought to exercise judgement and identify innovative solutions.

Impact:
• Significantly impact the achievement of operational, project, or department objectives; ensures quality standards are achieved; work is guided by business strategy.
Interpersonal Skills:
• Adapt style and use persuasion in delivering messages. Issues may be complex, audience perspectives may be divergent, and information may be non-routine in nature.
• Excellent written and verbal communication skills

What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply